Ondansetron
- Product NDC
- 11819-365
- 11-digit product format
- 118190365
- Labeler code
- 11819
- Product ID
- 11819-365_9ac5ef7b-9810-44b2-a5f6-07eac3feecc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- HHS/Program Support Center/Supply Service Center
- Application
- ANDA078139
- Marketing category
- ANDA
- Marketing start
- 2011-07-26
- Marketing end
- 0000-00-00
- Substance
- ONDANSETRON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11819-365-01 | Ondansetron | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 1 | | 1 |
| 11819-365-01 | Ondansetron | 5 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 5 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ondansetron | ACTIVE INGREDIENT | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| Ondansetron | ACTIVE MOIETY | 4AF302ESOS | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11819-365 | ONDANSETRON TABLET, ORALLY DISINTEGRATING [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER] | 1 | Legacy NDC, 2 package rows | 20120302_16ed3ca8-c85c-4d06-9c4f-d5bbf344b12e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 11819-365-01 | 11819036501 | 1 in 1 BLISTER PACK | Historical |